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Study of Lactobacillales and Lacidofil in Multiple Sclerosis Patients: Comparing Effectiveness of Probiotic Therapy

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with Multiple Sclerosis (MS), a condition affecting the central nervous system. The research aims to evaluate the effectiveness of probiotics (beneficial bacteria) in combination with standard MS treatments. The study will compare two different probiotic preparations: Lacidofil and Trilac, while some participants will not receive probiotics to serve as a comparison group.

During the study, all participants will continue their regular MS treatment with either ofatumumab (brand name Kesimpta) or ozanimod (brand name Zeposia). These are medications that help control MS symptoms by modifying the immune system. The probiotics will be taken as capsules by mouth daily for 24 months.

The study will track how well the treatments work by monitoring MS symptoms, conducting brain imaging with MRI scans, and assessing quality of life. Researchers will measure various aspects of participants' health, including pain levels, fatigue, and mental well-being through questionnaires. They will also monitor the number of MS relapses and any changes visible on brain scans.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    You will begin the trial while continuing your current multiple sclerosis (MS) treatment with either ozanimod or ofatumumab, which you must have been taking for at least 6 months

    Your medical history will be reviewed to confirm your MS diagnosis according to McDonald's criteria from 2017

    It will be verified that you haven't received steroid treatment in the past 3 months

  2. Step 2

    Treatment period start

    You will be randomly assigned to one of three groups: Trilac, Lacidofil, or control group

    You will continue taking your regular MS medication (ozanimod or ofatumumab)

    The probiotic medications are taken orally

  3. Step 3

    Monitoring at 12 months

    A brain MRI scan will be performed to check for any new or enlarged lesions

    You will complete several questionnaires about your health, including:

    Mental health assessment (GHQ-28 questionnaire)

    Pain assessment (VAS scale)

    Fatigue evaluation (Fatigue Analogue Scale)

    Quality of life assessment (SF-36 questionnaire)

  4. Step 4

    Final assessment at 24 months

    Another brain MRI scan will be performed

    The same questionnaires will be completed again

    Your overall disease activity will be evaluated

    Any side effects throughout the study period will be recorded

Who can join the trial?

6 criteria

  • Must have a confirmed diagnosis of multiple sclerosis according to McDonald's 2017 diagnostic criteria
  • Must be between 18 and 45 years old
  • Must provide voluntary consent to participate in the research study
  • Must not have received steroid treatment (medications like prednisone or methylprednisolone) in the last 3 months
  • Must have been receiving treatment with either ozanimod or ofatumumab (medications used to treat multiple sclerosis) for at least 6 months
  • Can be either male or female

Who cannot join the trial?

14 criteria

  • Age below 18 years or above 65 years
  • Pregnancy or breastfeeding
  • Active infection or serious illness other than multiple sclerosis
  • Use of antibiotics within 3 months before the study
  • History of gastrointestinal surgery (surgery involving stomach or intestines)
  • Known allergy to probiotics or any components of the study medications
  • Participation in another clinical trial within the last 30 days
  • Inability to follow study procedures or provide informed consent
  • Severe form of multiple sclerosis with high disability score
  • Current treatment with immunosuppressive medications (medicines that weaken the immune system)
  • History of alcohol or drug abuse in the past 12 months
  • Severe psychiatric conditions that could interfere with study participation
  • Significant abnormalities in blood tests
  • Uncontrolled medical conditions such as diabetes or high blood pressure
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Investigated drugs

Trilac is a probiotic medication containing beneficial bacteria that help maintain healthy gut flora. It is being studied for its potential effects in reducing the symptoms and disease activity in multiple sclerosis patients. Lacidofil is also a probiotic medication containing specific strains of beneficial bacteria. Like Trilac, it is being investigated for its potential role in managing multiple sclerosis symptoms through its effects on gut health and immune system function. Both medications represent a new approach to treating multiple sclerosis by focusing on the relationship between gut bacteria and immune system function. These probiotics are generally considered safe and are already used for various digestive health conditions.

What is already known about the treatment

  • Trilac

    A probiotic medication available in oral capsule form, containing beneficial bacteria that help maintain healthy gut flora. This medication is currently being studied in clinical trials for its potential effects in multiple sclerosis patients, representing an innovative approach to autoimmune disease management. While traditionally used for digestive health support, recent research explores its possible immunomodulatory properties and their impact on neurological conditions. The medication belongs to the class of probiotic supplements and works by colonizing the intestinal tract with beneficial bacteria, potentially influencing the gut-brain axis and immune system function.

  • Lacidofil

    A probiotic preparation administered orally in capsule form, containing specific strains of beneficial bacteria designed to support intestinal microbiota. Currently being evaluated in clinical trials for its potential therapeutic role in multiple sclerosis, this medication represents a novel approach to managing autoimmune conditions. Traditionally used for gastrointestinal health, it is now being studied for its possible effects on immune system regulation and neurological function. The medication belongs to the probiotic therapeutic class and functions by establishing beneficial bacterial colonies in the gut, which may influence systemic immune responses and neurological health through the gut-brain axis.

Investigated diseases

Multiple Sclerosis - A chronic disease affecting the central nervous system where the immune system damages the protective covering of nerve fibers. The disease typically causes inflammation and damage to myelin in the brain and spinal cord, disrupting communication between different parts of the nervous system. Symptoms can include fatigue, difficulty walking, vision problems, muscle weakness, and problems with coordination and balance. The disease usually follows a pattern of relapses and remissions, where symptoms may flare up and then improve. Multiple sclerosis affects each person differently, with varying patterns of symptoms and progression over time.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-520955-10-00Protocol codeABM/PROTECT-MS/2025Estimated enrolment210 patientsSponsorWojskowy Instytut Medyczny Panstwowy Instytut Badawczy

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